Oral Dosage Form New Animal Drugs; Phenylbutazone Tablets
other · Food and Drug Administration · Rule · Published 2008-02-13 · Effective 2008-02-13 · 73 FR 8192
Document
Document number
E8-2608
Federal Register citation
73 FR 8192
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2008-02-13
Effective date
2008-02-13
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by IVX Animal Health, Inc. The supplemental NADAs provide revised labeling for phenylbutazone tablets used in horses and dogs.